Approval of Cow Hormone Imperils Our Milk

Published: December 22, 1990

To the Editor:

In "Milk With Experimental Hormone Is Safe for Humans, a Panel Finds" (news article, Dec. 8), you report the endorsement by a National Institutes of Health panel of genetically engineered or biosynthetic bovine growth hormones to increase milk production. The endorsement raises critical questions on the safety of our dairy products and on procedures for technology assessment.

I am one of the few independent scientists who have investigated the veterinary and potential public health hazards of the biosynthetic hormones, which differ chemically from their natural versions, and who actively participated in the N.I.H. conference, which was heavily dominated by the dairy industry and its indentured academics. I charge that the panel's unqualified endorsement of the hormones is a naive whitewash.

The conclusion of the panel was based almost exclusively on published claims by the industry and its academic consultants and contractees, though the more critical of these claims are generally controverted by their underlying data. Analysis of these data show that claims for the effectiveness of the manufactured hormones in increasing milk production are exaggerated.

More serious, the industry data, despite manipulation, also show that cows hyperstimulated by repeated hormone injections undergo serious stress, as evidenced by a high incidence of reproductive failure and chronic mastitis. Evidence of such adverse effects was confirmed and extended in confidential Monsanto files submitted in 1987 to the Food and Drug Administration, which were anonymously leaked in November 1989. These files also showed evidence of organ toxicity and widespread pathological lesions; of increased hormone levels in milk, and of extensive use of illegal and unapproved antibiotics and drugs to control infectious disease in the hormone-treated cows, with resulting risks of milk contamination.

On the basis of such information, the House Committee on Government Operations charged last May 8 "that Monsanto and the F.D.A. have chosen to suppress and manipulate animal health test data -- in efforts to approve commercial use" of the hormones. The committee requested the inspector general of the Department of Health and Human Services to begin an immediate investigation.

Last August, at the early planning stages of the N.I.H. conference, I warned of these serious concerns on the unreliability of published claims on the safety of the hormones by the industry and its academics, and asked that the N.I.H. request the industry to provide the panel with unexpurgated toxicology files. Unsuccessful in this effort, I provided the N.I.H. with the executive summary of the 1987 Monsanto files and asked that copies be sent to the panel.

At the conference, I asked the panel chairman how he could reconcile the published industry claims on safety with the unpublished Monsanto files, to which he replied that he was unaware of them. After I had provided him with a copy of the executive summary, he informed me that the panel could not consider them as they were marked "confidential." However, in an address to the conference, I quoted from these files and warned of the suppression of critical data by the industry and the need for independent scientific review of the raw data base. Yet the panel ignored these data.

The panel's conclusions and report are marred by other major defects. For instance, the report reassuringly states that "milk is the most monitored food in the American food supply," despite warnings during the conference on recent evidence of widespread contamination of milk with antibiotic residues and F.D.A. acknowledgment that "the illegal use of veterinary drugs can be an even greater threat to the public health than the illegal use of human drugs."

Furthermore, a report last November by the General Accounting Office, which is investigating F.D.A. review of the milk hormones for alleged improprieties, further documents the contamination of milk and the gross inadequacies of F.D.A. monitoring. More surprising is the contrast between the panel's unqualified endorsement of the safety of the new hormones and its recommendations for further research on a wide range of health and safety concerns.

The N.I.H. and its panel do not appear to have recognized that the usefulness of technology assessment depends on the availability of a valid data base, as opposed to derived publications, which may too easily reflect suppression, manipulation and self-interest. SAMUEL E. EPSTEIN, M.D. Professor of Occupational and Environmental Medicine, University of Illinois Medical Center Chicago, Dec. 11, 1990